Summary:
Summary Statement of Deficiencies D0000 REVISED COPY D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) evaluation/competency records since 5/12 /17 for blood gas TP listed as #4, #8 and #10 on the Centers for Medicare & Medicaid Services (CMS) 209 form and interview with the respiratory department supervisor at 11:30 am on the day of survey, 4/3/19, the technical consultant failed to include in the six-month evaluations the 6 procedures required for minimal regulatory assessment of competency for 3 of 14 personnel performing blood gas testing . Findings include: 1. Observation of the CMS 209 testing personnel form listed the blood gas testing personnel. 2. Observation of the personnel records including competency evaluations for all respiratory testing personnel for 2018 and 2019 revealed the technical consultant did not include the 6 required procedures for assessing competency during the six-month evaluation of TP #4 (initial training 1/28/18), #8 (initial training 4/25 /18) and #10 (initial training 3/20/18). 3. Interview with TP #1 at 11:30 am on 4/3/19 confirmed the six-month competency for three blood gas personnel did not include all 6 procedures for assessing competency The 6 procedures required for minimal regulatory requirements for assessment of competency include: a. Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; b. Monitoring the recording and reporting of test results; c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d. Direct observations of performance of instrument maintenance and function checks; e. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and f. Assessment of problem solving skills. -- 2 of 2 --